Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Femtolaser Assisted Keratoplasty Versus Conventional Keratoplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03619434
Recruitment Status : Not yet recruiting
First Posted : August 7, 2018
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
University of Southampton

Brief Summary:

This pilot study will compare upto 15 patients undergoing femtolaser assisted keratoplasty (using CE[Conformité Européene] approved femtolaser apparatus) with upto 15 patients undergoing conventional keratoplasty with a manual trephine. Patients will be randomly assigned to either group. All keratoplasties will be penetrating keratoplasties. The following aims of this research is detailed below:

  1. Does femtosecond laser assisted keratoplasty ( FLAK ) yield faster visual recovery and better long term BCVA (Best Corrected Visual Acuity)?
  2. Does FLAK offer a biomechanically stronger cornea and thereby more safety and less risk of wound dehiscence?
  3. Is there any difference between FLAK and conventional keratoplasty in terms of graft failure or rejection?

Follow up in best corrected visual acuity, various refraction/astigmatism measurements, intraocular pressure, graft rejection/failure rates, pachymetry and corneal hysteresis and resistance factor will be recorded at 1 day, 1 week, 1, 3 and 6 months and 1 year and 18 months postoperatively.

This study, to the investigators' knowledge will be the first randomised controlled trial in this area, the first to provide an empirical measurement to biomechanical stability of the cornea with the femtolaser, and the first done in an NHS (National Health Service) setting.


Condition or disease Intervention/treatment Phase
Keratoconus Fuchs Dystrophy Corneal Disease Procedure: Femtosecond Laser Procedure: Trephine blade Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

This is a prospective cohort study where a maximum of 30 patients attending the cornea firm at the eye unit in University Hospitals Southampton who are indicated for penetrating keratoplasty as a result of corneal disease or pathology will be recruited.

All patients will receive a complete ophthalmological examination preoperatively.

Subjects will then be divided randomly into 2 groups of 15, should we get 30 patients;

Masking: None (Open Label)
Masking Description: No masking as the investigators are assessing differences in surgical technique
Primary Purpose: Treatment
Official Title: Pilot Study of Femtolaser Assisted Keratoplasty Versus Conventional Keratoplasty
Estimated Study Start Date : November 30, 2018
Estimated Primary Completion Date : April 26, 2019
Estimated Study Completion Date : December 20, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Conventional keratoplasty group (Control)
This group will undergo conventional penetrating keratoplasty with a trephine blade.
Procedure: Trephine blade
A trephine blade will be used to make incisions in the cornea for the graft

Experimental: Femtolaser group
This group will undergo femtosecond laser-assisted penetrating keratoplasty.
Procedure: Femtosecond Laser
The laser will be used to make incisions in the cornea for the graft.




Primary Outcome Measures :
  1. Best Corrected Visual Acuity [ Time Frame: Followed up periodically for upto 18 months ]
    Measure of clarity of vision

  2. Subjective refraction [ Time Frame: Followed up periodically for upto 18 months ]
    A measure of refractive error

  3. Intraocular pressure [ Time Frame: Followed up periodically for upto 18 months ]
    Fluid pressure inside the eye

  4. Corneal hysteresis [ Time Frame: Followed up once at 3 months ]
    Measure of biomechanical stability of the cornea. Will be done by one machine (Ocular Response Analyser)

  5. Corneal topography [ Time Frame: Followed up periodically for upto 18 months ]
    A visual outcome measure assessing corneal curvature. Will be done using a pentacam.

  6. Endothelial cell density [ Time Frame: Followed up periodically for upto 18 months ]
    A measure of healing in the new graft

  7. Corneal Resistance Factor [ Time Frame: Followed up once at 3 months ]
    Measure of biomechanical stability of the cornea. Will be done by one machine (Ocular Response Analyser)

  8. Keratometry [ Time Frame: Followed up periodically for upto 18 months ]
    A visual outcome measure assessing corneal curvature. Will be done using a pentacam.

  9. Pachymetry [ Time Frame: Followed up periodically for upto 18 months ]
    A visual outcome measure assessing corneal thickness. Will be done using a pentacam,

  10. Corneal irregularity index [ Time Frame: Followed up periodically for upto 18 months ]
    A visual outcome measure assessing corneal curvature. Will be done using a pentacam.

  11. Astigmatism [ Time Frame: Followed up periodically for upto 18 months ]
    A visual outcome measure assessing corneal curvature. Will be done using a pentacam.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   16 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Eyes with corneal opacities owing to previous corneal pathology.

Exclusion Criteria:

  • Eyes with concomitant ocular pathology which may affect visual acuity.
  • Eyes who received previous corneal grafts.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03619434


Contacts
Layout table for location contacts
Contact: Parwez N Hossain, MB ChB, PhD 02381204270 P.N.Hossain@soton.ac.uk

Locations
Layout table for location information
United Kingdom
Southampton Eye Unit Not yet recruiting
Southampton, Hampshire, United Kingdom, SO16 6YD
Contact: Parwez Hossain, MhCHb, PhD    02381204270    P.N.Hossain@soton.ac.uk   
Principal Investigator: Parwez Hossain, MhCHb, PhD         
Sub-Investigator: Joshua Adeyoju, Student         
Sub-Investigator: Omar El-Haddad, Corneal Research Fellow         
Sponsors and Collaborators
University of Southampton
Investigators
Layout table for investigator information
Principal Investigator: Parwez Hossain, B ChB, PhD University of Southampton

Layout table for additonal information
Responsible Party: University of Southampton
ClinicalTrials.gov Identifier: NCT03619434     History of Changes
Other Study ID Numbers: 32158
First Posted: August 7, 2018    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Southampton:
Femtolaser
Corneal Transplant
Keratoplasty
Corneal Graft
Laser
Trephine

Additional relevant MeSH terms:
Layout table for MeSH terms
Keratoconus
Corneal Diseases
Fuchs' Endothelial Dystrophy
Eye Diseases
Corneal Dystrophies, Hereditary
Eye Diseases, Hereditary
Genetic Diseases, Inborn